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临床试验/NCT01141348
NCT01141348已完成不适用

Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise

University of North Carolina, Chapel Hill12 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
12
主要终点
Weight Change difference between baseline and 4 month follow-up

研究概览

简要总结

The overall goal of the translational research is to evaluate the processes and outcomes of implementing, in a range of public health agencies, an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. The intervention was originally studied in a single coordinated community health care center/church setting and delivered by research staff. The investigators will evaluate the intervention's translation and test its effectiveness as implemented by existing staff in six public health agencies supported by local community resources.

详细描述

Low-income women in the US have the highest rates of overweight and obesity, putting them at increased risk for diabetes, heart disease, and other chronic illnesses. Because mean body mass index gradually increases during adult life and peaks at 50-59 years of age, low income women between 40-64 years are a group deserving of special attention. While there is sufficient evidence that some behavioral weight management interventions are effective in producing clinically meaningful levels of weight loss with reductions in cardiovascular risk factors and delayed onset of diabetes, there is a research gap in translating these efficacious interventions to real life settings and diverse population groups. Research that seeks to translate effective behavioral weight management interventions from resource-intensive efficacy trials to long-term adoption and implementation by public health settings serving a diverse low-income population is timely and of great public health significance. This translational research can provide important information to decision-makers about evidence-based intervention delivery, resource allocation, and workforce preparation.

The overall goal of the proposed research is to evaluate the processes and outcomes of translating from research to practice an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. Originally studied in a single coordinated community health care center/church setting and delivered by research staff (Weight-Wise Pilot Study), we will evaluate the translation of and test the effectiveness of this intervention as implemented by existing staff in a range of county health departments supported by local community resources.

To evaluate the translation process, we will use the RE-AIM framework, diffusion of innovation theory, and systematic models of adaptation to assess: 1) factors related to reach; contextual or setting-specific factors necessary for successful adoption and implementation; 2) effectiveness of facilitator training and stakeholder collaborations; 3) adaptation and fidelity during implementation; and 4) costs associated with the implementation and outcomes. To test the intervention's effectiveness, we will enroll 240 overweight or obese low-income women, 40-64 years of age, at 6 representative public health agencies. Participants will be randomized to receive a 16-week behavioral weight loss intervention (special intervention group) or usual care (wait listed control group). The primary study outcome at 5 month follow-up is weight change; secondary outcomes include change in blood pressure, dietary intake, physical activity, and quality of life measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI between 27.5 and 45
  • willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
  • English-speaking
  • able and willing to give informed consent
  • household income less than or equal to 250% of federal poverty guidelines.

排除标准

  • medical or physical limitations to engaging in moderate level physical activity
  • medical or other contraindications to weight loss
  • history of gastric bypass surgery or scheduled surgery for this purpose
  • weight loss of > 20 lbs in the last 3 months
  • current use of medication for weight loss
  • treatment of psychosis
  • diagnosis of Type 1 diabetes.

结局指标

主要结局

Weight Change difference between baseline and 4 month follow-up

时间窗: Baseline and 4 month follow-up

次要结局

  • Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up(Baseline and 4 month follow-up)

研究者

申办方类型
Other

研究点 (12)

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